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放射治疗与依托泊苷联合治疗新诊断恶性胶质瘤患者的II期研究。

Phase II study of a radiotherapy/etoposide combination for patients with newly malignant gliomas.

作者信息

Beauchesne P, Soler C, Rusch P, Fotso M J, Duthel R, Schmitt T, Brunon J

机构信息

Service de Neurochirurgie, CHU de Saint-Etienne, Hôpital de Bellevue, Saint-Etienne, France.

出版信息

Cancer Chemother Pharmacol. 1999;44(3):210-6. doi: 10.1007/s002800050969.

DOI:10.1007/s002800050969
PMID:10453722
Abstract

PURPOSE

Etoposide, a semisynthetic derivative of podophyllotoxine, is a topoisomerase II inhibitor. This drug is currently used in several types of human cancer. The aim of this study was to evaluate the efficacity and tolerance of a near-concurrent association of radiotherapy and etoposide for newly malignant gliomas.

METHODS

From May 1995 to December 1996, 30 malignant glioma patients were included in this phase II study; 16 patients underwent surgical tumor resection, and a stereotactic biopsy was performed in 14 patients. Standard cranial irradiation and six courses of etoposide (100 mg/m2, x days 1-3) were administered. The first course of etoposide was administered on days 1-3 of radiotherapy and was resumed in the week following the end of radiotherapy. Treatment was consolidated by further courses of etoposide every 4 weeks.

RESULTS

Only 26 patients could be evaluated for the purpose of our study. The median age was 60.1 years, and the median Karnofsky performance score (KPS) was 80.2. The rate of objective response for evaluable patients was 34.6%, and four complete responses (CR) and five partial responses (PR) were noted. The median survival (MST) was 12 months, and the average overall survival was 12.5 months. Hematological toxicity was mild, and grade 3 or 4 neutropenia (white blood cell count < 1500/ml) was noted in three patients, without any sepsis or bleeding.

CONCLUSIONS

The results obtained in this study are comparable to the best reported results on the combination of radiotherapy and nitrosoureas. The near-concurrent combination of radiotherapy and etoposide seems to be effective and well tolerated in the treatment of newly malignant gliomas.

摘要

目的

依托泊苷是鬼臼毒素的半合成衍生物,是一种拓扑异构酶II抑制剂。该药物目前用于多种类型的人类癌症。本研究的目的是评估放疗与依托泊苷近同期联合应用于新诊断的恶性胶质瘤的疗效和耐受性。

方法

1995年5月至1996年12月,30例恶性胶质瘤患者纳入本II期研究;16例患者接受了肿瘤手术切除,14例患者进行了立体定向活检。给予标准的头颅照射和六个疗程的依托泊苷(100mg/m²,第1 - 3天)。依托泊苷的第一个疗程在放疗的第1 - 3天给药,并在放疗结束后的一周内恢复。每4周通过进一步的依托泊苷疗程巩固治疗。

结果

仅26例患者可纳入本研究评估。中位年龄为60.1岁,中位卡诺夫斯基表现评分(KPS)为80.2。可评估患者的客观缓解率为34.6%,观察到4例完全缓解(CR)和5例部分缓解(PR)。中位生存期(MST)为12个月,平均总生存期为12.5个月。血液学毒性较轻,3例患者出现了3级或4级中性粒细胞减少(白细胞计数<1500/ml),无任何败血症或出血情况。

结论

本研究获得的结果与放疗和亚硝基脲联合应用的最佳报道结果相当。放疗与依托泊苷的近同期联合应用在新诊断的恶性胶质瘤治疗中似乎有效且耐受性良好。

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